The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued an infringement notice for $12,600 to Sydney-based company GenesisCare Clinical CRO Pty Ltd for the alleged unlawful importation of KN95 face masks in relation to COVID-19.
GenesisCare allegedly breached a condition of the Therapeutic Goods (Medical Devices-Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 (the exemption) by importing KN95 face masks that were not, at the time of the importation, included in the Australian Register of Therapeutic Goods (ARTG) and were not being imported for supply to the National Medical Stockpile.
The exemption facilitates the purchase of specified types of medical devices by the Australian Government Department of Health to ensure the National Medical Stockpile has enough personal protective equipment (PPE) to assist in reducing the spread of COVID-19 between individuals and healthcare professionals. GenesisCare is not under a contract with the Australian Government Department of Health, or another agency of the Commonwealth acting on behalf of the Australian Government Department of Health, for this purpose.
Under the Therapeutic Goods Act 1989 (the Act), therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia, unless a specific exemption, approval or authority applies. Where therapeutic goods are covered by an exemption, the conditions of the exemption must be complied with. Failure to do so exposes a company or any relevant individual to criminal prosecution or civil penalty proceedings.
The TGA is supporting suppliers of products that are not covered by the exemption to include them on the ARTG as a priority.
The TGA has published guidance on face masks and respirators that are regulated by the TGA. This guidance helps consumers, health professionals, and government officials to determine when a face mask is a medical device and therefore must be included in the ARTG.
Breaches of the Act are of significant concern to the TGA given the current pandemic. The TGA’s highest priority is to protect the health and safety of the Australian public through regulation of therapeutic goods.
The TGA takes action against breaches of the Act
The regulatory scheme is critical to the safety of Australian consumers and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.